Recall Z-1801-2020 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips North America, LLC
Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.
| Date | Mar 5, 2020 |
| Status | Terminated |
| Reason | No torque was specified for the four screws that connect the gearbox and the mounting flange within the C-arm roll motor which could result in the screws becoming loose.. |
| Root cause | Component design/selection |
| Action | The firm, Philips, sent an "URGENT-MEDICAL DEVICE CORRECTION" letter to the US and an "URGENT-Field Safety Notice" letter to the OUS (foreign countries) dated 2/26/20 on 3/5/2020 to all consignees by certified mail. These letters to all users explained that no torque was specified for the screws that connect the gearbox and the mounting flange within the C-arm roll motor assembly. A low torque could cause stress on the system and result in a loosening of the screws. If this occurs, the C-arm could rotate freely and uncontrolled movement could cause collision and/or entrapment. Philips asked th |
| Quantity | 162 units |
| Distribution | Worldwide distribution: US (nationwide) including the following states: Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181830 | Azurion R2.0 Philips Medical Systems Nederland B.V., Aug 2, 2018 |